510(k) · Cleared
ClearedSpiral Radius Rodding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 10, 2000 as substantially equivalent to K992784 (United States Surgical, A Division of Tyco Healthc, 1999) after a 67-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Mar 10, 2000
- Review
- 67 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970635 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 3 generations backK974213 Aurora Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- 2 generations backK983197 Surgical Dynamics Rodding System (Previously Known as the Aurora…United States Surgical, A Division of Tyco Healthc · 1998
- 1 generation backK992784 Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999
- This deviceK000009 Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000
- Descendant · cites it directly · 0 of its ownK012273 Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001
Most influential descendants
Showing 1 of 1 · See all- K012273Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970635 | Titanium Spinal Rod System | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −3 | K974213 | Aurora Titanium Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| −2 | K983197 | Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium… | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| −1 | K992784 | Next Generation Rodding System | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| 0 (this device) | K000009 | Spiral Radius Rodding System | United States Surgical, A Division of Tyco Healthc | 2000 | — |
| +1 | K012273 | Spiral Radius 90-D SST System | United States Surgical, A Division of Tyco Healthc | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992784 | Next Generation Rodding SystemSummary page 1…Titanium Spinal Rod System PROPRIETARY NAME: Spiral Radius Rodding System PREDICATE DEVICES: USS's Spiral Radius Rodding System - K992784 INTENDED USE: The components of the Spiral Radius Rodding System are indicated for spinal fi… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012273 | Spiral Radius 90-D SST System | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K012273 (United States Surgical, A Division of Tyco Healthc, 2001) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992784.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The components of the Spiral Radius Rodding System are indicated for spinal fixation. When used as an ante rolateraI/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative…
Read the full statement (356 words)
The components of the Spiral Radius Rodding System are indicated for spinal fixation.
When used as an ante rolateraI/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine-, and hook and sacralfiliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoiiosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K000009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000009: Spiral Radius Rodding System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026